MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX450 PATIENT MONITOR

Model Number 866062 (MX450)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Electric Shock (2554)

Event Date 12/30/2018

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.Patient information has been requested, not available at time of report.

Event Description

The customer states a nurse was shocked while plugging the power cord.The report indicates that there was an injury, due to the shock; the extent of the injury was unknown at the time this report was due.

Manufacturer Narrative

A philips field support engineer (fse) traveled to the customer site to evaluate the issue.The fse found that the power cord attached to the intellivue mx450 patient monitor was missing the ground connection and several cuts were found in the power cord.The power cord, shorted out when tested from the hole to either side of the connectors.The fse stated that this caused the main board to malfunction and show the red screen.The power cord was replaced with one from the customer stock and the fse replaced the main board.The nurse was treated on site with no indication of any loss of work.The device remains on site and in use at the customer site.No subsequent calls have been logged for this device/issue.No further investigation or action is warranted at this time.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: INTELLIVUE MX450 PATIENT MONITOR
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 8277321
• MDR Text Key: 134082264
• Report Number: 9610816-2019-00022
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K130849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866062 (MX450)
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/31/2018
• Initial Date FDA Received: 01/25/2019
• Supplement Dates Manufacturer Received: 12/31/2018
• Supplement Dates FDA Received: 09/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other